U.S. patent application number 11/371418 was filed with the patent office on 2006-08-03 for set for blood processing.
Invention is credited to G. Keith Andrews, James M. Brugger, William J. Schnell, David S. Utterberg.
Application Number | 20060173395 11/371418 |
Document ID | / |
Family ID | 36757594 |
Filed Date | 2006-08-03 |
United States Patent
Application |
20060173395 |
Kind Code |
A1 |
Brugger; James M. ; et
al. |
August 3, 2006 |
Set for blood processing
Abstract
A combined arterial and venous blood tubing set is provided for
transport of blood between a patient and a blood processing unit.
The set comprises an arterial set component comprising arterial
tubing having an arterial patient connector at one end and an
arterial unit connector at the other. A venous set component has
venous tubing with a venous patient connector at one end and a
venous unit connector at the other end. The arterial and venous
patient connectors, and the arterial and venous unit connectors,
are respectively, substantially, and releasably directly connected
to each other. As a result of this, the arterial, and venous set
components cooperate to form a loop. Other features of improved
sets are also disclosed.
Inventors: |
Brugger; James M.; (Newbury
Port, MA) ; Utterberg; David S.; (Seattle, WA)
; Schnell; William J.; (Libertyville, IL) ;
Andrews; G. Keith; (Coupeville, WA) |
Correspondence
Address: |
SEYFARTH SHAW LLP
55 E. MONROE STREET
SUITE 4200
CHICAGO
IL
60603-5803
US
|
Family ID: |
36757594 |
Appl. No.: |
11/371418 |
Filed: |
March 9, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10076196 |
Feb 12, 2002 |
|
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11371418 |
Mar 9, 2006 |
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Current U.S.
Class: |
604/6.09 |
Current CPC
Class: |
A61M 1/3627 20130101;
A61M 1/3621 20130101; A61M 39/20 20130101; A61M 1/3644 20140204;
A61M 1/3643 20130101 |
Class at
Publication: |
604/006.09 |
International
Class: |
A61M 37/00 20060101
A61M037/00 |
Claims
1. A tubular medical fluid set comprising a bubble trap chamber
having a top wall and a side wall, said top wall defining a port
which communicates with flow tubing, said port communicating with a
port tube extending longitudinally into said chamber adjacent to
said side wall, said port tube forming a baffle whereby medical
fluid entering said chamber through said port is directed through
the port tube and circumferentially about said chamber side wall
and the baffle causing a turbulent flow.
2. The tubular set of claim 1 wherein the chamber includes a second
baffle for interrupting the circumferential flow.
3. The tubular set of claim 1 wherein the chamber provides for an
airspace at the top wall.
4. The tubular set of claim 1 wherein the port tube includes an
inner tube spaced below the wall, the inner tube including an end
having an aperture that directs flow circumferentially out of the
inner tube end.
5. The tubular set of claim 4 wherein the port tube is formed by a
tubular wall and the aperture is formed at least partially in the
tubular wall.
6. A tubular medical fluid set comprising an in-line bubble trap
chamber having a top wall and a tubular side wall, said top wall
defining a port which communicates with flow tubing of said tubular
set, said port directing flow circumferentially into said bubble
trap chamber, whereby medical fluid entering said chamber through
said port is directed circumferentially about said chamber side
wall and a baffle disposed within the chamber to cause a turbulent
flow, to prevent formation of a whirlpool.
7. The tubular set of claim 6 wherein the flow tubing forms the
baffle.
8. The tubular set of claim 6 wherein the port forms the
baffle.
9. The tubular set of claim 6 wherein the port comprises a port
tube that extends longitudinally into the chamber adjacent the
sidewall and receives medical fluid from the flow tubing.
10. The tubular set of claim 9 wherein a portion of the port tube
forms the baffle.
11. The tubular set of claim 9 further comprising a component
disposed within the chamber and the component forms the baffle.
12. The tubular set of claim 9 wherein the chamber includes
multiple baffles.
13. The tubular set of claim 6 wherein the chamber includes air
trapped therein.
14. The tubular set of claim 6 wherein microbubbles are disposed
within the chamber.
15. The tubular set of claim 6 wherein air is vented out of the
chamber.
16. The tubular set of claim 6 in which said chamber defines a
liquid level therein having a predetermined air volume which has a
volume of at least 4 cc.
17. A tubular medical fluid set comprising a bubble trap chamber
having a top wall, a port communicating with flow tubing of the
tubular set, said port communicating with a port tube extending
into said chamber, said port tube having an aperture spaced below
said top wall, said aperture being positioned to direct flow out of
said tube circumferentially into the bubble trap chamber, whereby
blood entering said chamber through said aperture is directed
circumferentially about said chamber, said chamber having a
component which serves as a baffle, said baffle being radially
outwardly spaced from a center of said chamber and extending
longitudinally along an upper portion of said chamber and the
baffle causes turbulent flow at the level of said baffle.
18. The tubular set of claim 17 wherein the aperture is formed at
an inner tube end of the port tube.
19. The tubular set of claim 17 wherein the aperture is formed in a
side of the port tube.
20. The tubular set of claim 17 wherein the port tube forms the
baffle.
21. The tubular set of claim 17 wherein the chamber includes
multiple baffles.
22. The tubular set of claim 17 in which said baffle comprises a
tube that is joined to an inner surface of a side wall of said
bubble trap.
23. The tubular set of claim 22 in which said port tube also
extends longitudinally and comprises a tube that is joined to an
inner surface of a side wall of said bubble trap.
24. The tubular set of claim 17 in which said chamber defines a
liquid level therein having a predetermined air volume which has a
volume of at least 4 cc.
25. The tubular set of claim 17 in which said port tube also
extends longitudinally and comprises a tube that is joined to an
inner surface of a side wall of said bubble trap.
26. A bubble trap chamber comprising: a port for receiving blood
and whereby blood entering said chamber through said port is
directed circumferentially about said chamber, a first chamber
portion defining a turbulent blood area where interference with the
circumferential flow of blood is provided at a position that is
radially outwardly spaced from a center of the chamber; and a
second chamber portion defining a circumferential flow area where a
substantially circumferential flow of blood is provided and air
bubbles in the blood rise from the circumferential flow area
upwardly through the turbulent blood area.
27. The bubble trap chamber of claim 26 further comprising a top
wall and the port disposed in the top wall.
28. The bubble trap chamber of claim 26 further comprising a port
tube extending longitudinally into the chamber and in communication
with the port, the port tube extending through the first chamber
portion and into the second chamber portion.
29. The bubble trap chamber of claim 28 wherein the port tube
includes an aperture that is oriented at an end of the port tube
and the aperture expels blood into the second chamber portion in a
substantially circumferential flow.
30. The bubble trap chamber of claim 26 further comprising a baffle
disposed within the chamber within the first chamber portion, the
baffle interfering with the substantially circumferential flow of
blood and creating turbulence.
31. The bubble trap chamber of claim 26 further comprising a
longitudinal axis of the chamber and a port tube extending
longitudinally into the chamber substantially parallel to the
longitudinal axis and radially spaced from the longitudinal
axis.
32. The bubble trap chamber of claim 26 wherein the first chamber
portion is located at a different height within the chamber than
the second chamber portion.
33. The bubble trap chamber of claim 26 in which said blood in said
chamber below said first chamber portion is free to flow
circumferentially without direct interference by a baffle.
34. The bubble trap chamber of claim 26 further comprising a baffle
disposed in the chamber that comprises a tube other than said port,
said other tube being joined to an inner surface of a side wall of
said bubble trap chamber.
35. The bubble trap chamber of claim 26 further comprising an
aperture formed by a port tube in communication with the port and
in which said aperture defines a single flow inlet.
36. The bubble trap chamber of claim 35 wherein the aperture is
formed in a side wall of the port tube.
37. A method of processing fluid between turbulent and
non-turbulent areas in a chamber, the method comprising the steps
of: providing a chamber having a port and a baffle; receiving a
fluid flow through the port; expelling fluid from the port into the
chamber in a substantially circumferential flow; and interfering
with the substantially circumferential flow of fluid by exposure to
the baffle at a position that is radially outwardly spaced from a
center of the chamber in order to provide a substantially turbulent
flow in a first area that is spaced from a second area of less
turbulent flow.
38. The processing method of claim 37 further comprising the steps
of: forming a partially circumferential flow in the second area;
driving microbubbles from the second area to the first area; and
causing the microbubbles to rise upwardly through the turbulent
flow.
39. The processing method of claim 37 wherein the chamber includes
a port tube extending into the chamber from the port, and the port
tube includes an aperture for expelling the fluid into the chamber
in a substantially circumferential flow.
40. The processing method of claim 37 further comprising the step
of causing microbubbles to rise into an airspace at top of the
chamber.
41. The processing method of claim 37 further comprising the step
of venting microbubbles out of the chamber.
42. A protector for a female luer connector, which comprises: an
outer sleeve, a central transverse wall defined in said outer
sleeve, a male luer projecting axially within said sleeve from said
transverse wall to engage said female luer connector within the
sleeve; a tube projecting axially within said sleeve from said
transverse wall in the direction opposed to said male luer, said
tube and male luer having connected lumens, said tube having an
outer end that is substantially recessed within said sleeve.
43. The protector of claim 42 in which said sleeve has an inner
wall free of screw threads.
44. The protector of claim 43 in which said sleeve inner wall
defines axially extending ribs to facilitate axially sliding
connection and retention with a female luer connector.
45. The protector of claim 42 in which said tube outer end
terminates at a point no more than about two thirds of the distance
from the transverse wall to the end of the tube opposed to said
male luer.
46. The protector of claim 45 in which a hinged cap is attached to
said outer sleeve in a position permitting closure of said cap over
the outer sleeve end that is opposed to said male luer.
47. The protector of claim 42 in which said sleeve has an inner
wall free of screw threads, said inner wall defining axially
extending ribs to facilitate axially sliding connection and
retention with a female luer connector, said tube outer end
terminating at a point no more than about two-thirds of the
distance from the transverse wall to the end of the tube opposed to
said male luer.
48. The protector of claim 47 in which a hinged cap is attached to
said outer sleeve in a position permitting closure of said cap over
the outer sleeve end that is opposed to said male luer.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This is a continuation of co-pending application Ser. No.
10/076,192, filed Feb. 13, 2002.
BACKGROUND OF THE INVENTION
[0002] The present invention pertains to a set for blood
processing. The field of blood processing primarily comprises
hemodialysis and plasmapheresis, although other forms of blood
treatment may also be used, for example, hemoperfusion, passing
blood through adsorbent cartridges, and the like. To accomplish
this, blood sets are used to convey blood from the patient to a
blood processing device, and then to return the blood from the
device back to the patient. The former blood set is called the
arterial set, while the latter set is called the venous set.
[0003] In combination, the arterial and venous sets comprise
several yards of tubing, and thus are rather cumbersome to handle.
Furthermore, cost is of course a critical matter, especially when a
patient has a chronic need for treatment as in hemodialysis, so
that even small cost savings can add up to a substantial amount
over a year or more of repeated usage of disposable arterial and
venous sets.
[0004] Furthermore, priming of the sets is an issue requiring the
skilled attention of technicians, so that any improvement or
simplification in the priming process, and other processes of use
of the arterial and venous sets, can be valuable.
[0005] By this invention, numerous improvements to conventional
arterial and venous blood sets are provided for reduction of cost
and improved ease and efficiency of use.
SUMMARY
[0006] By this invention, a combined arterial and venous blood
tubing set may be provided for the transport of blood between a
patient and a blood processing unit. The combined set comprises an
arterial set component which comprises arterial tubing having an
arterial patient connector at one end and an arterial unit
connector at the other end. A venous set component of the set
comprises venous tubing having a venous patient connector at one
end and a venous unit connector at the other end.
[0007] In accordance with this invention, the arterial and venous
patient connectors, and the arterial and venous unit connectors,
are respectively substantially and releasably directly connected to
each other in such manner that the arterial and venous set
components cooperate to form a loop.
[0008] This facilitates the installation of the sets into a
hemodialysis machine, for example, resulting in greater ease of
installation with a saving of time. Eventually, the set components
wind up serving in the normal manner of arterial and venous sets.
Even with a relatively small increase or improvement in ease and
time saving, the improvement can be quite substantial particularly
in the treatment of chronic conditions, as in most hemodialysis, so
that the effect of the improvement in time savings can add up to a
substantial amount over the course of a year.
[0009] Particularly, the arterial and venous unit connectors may be
directly connected together with a frangible seal, to permit their
breaking apart after the combined set has been primed, for
subsequent connection to a blood processing unit.
[0010] Thus, the fully primed arterial and venous sets may be
directly connected to a reused dialyzer. Solution may then be
circulated through the system with air being removed from the
dialyzer, but no air being sent to the dialyzer through the primed
sets, which reduces the number of air bubbles being trapped within
the dialyzer itself. Air coming from the dialyzer will then be
typically removed by a bubble trap in the sets, so that it is not
recirculated again to the dialyzer.
[0011] By this invention, particularly wet, reused dialyzers (or
other blood processing devices) can be effectively primed to
exhibit improved performance because of a reduced number of trapped
air bubbles within the membrane system of the dialyzer.
[0012] The arterial and venous patient connectors of the respective
arterial and venous sets may optionally be substantially directly
connected together by an interconnector tube to permit circulatory
priming of the arterial and venous sets, and also to avoid the need
of other end closures at the arterial and venous patient
connectors, if the arterial and venous sets are supplied to the
user in interconnected form as in this invention.
[0013] The interconnector tube preferably comprises a tube having a
connector such as a female luer connector at each end, for
connection with the patient connectors of the arterial and venous
sets. Also, the tube may have an attached, integral cap to close an
end of the tube after disconnection of one of the patient
connectors. Thus, one of the patient connectors may have its
sterility preserved while the other patient connector is being
attached to a fistula set and access to the patient's bloodstream
is being obtained.
[0014] Priming of the connected arterial and venous sets can be
performed in a manner similar to that disclosed in Utterberg U.S.
Pat. No. 5,951,870, preferably with the modifications described
below:
[0015] The arterial and venous sets respectively preferably have
the substantially directly connected end connectors to form a
closed loop as described above. One may pass priming solution into
and through a portion of the directly connected arterial and venous
sets in a first direction that is reversed to the normal direction
of blood flow through the sets, while removing air from one of the
sets through a branching port from one of the sets.
[0016] One also may pass priming solution into a second direction
of flow opposite to the first flow direction through the system
(which opposite direction is the normal direction of flow through
the system) while continuing to remove air from the system through
the port, until substantially all air desired is removed from the
arterial and venous sets.
[0017] Thereafter, with the flow stopped temporarily the unit
arterial and venous connectors are separated and connected to the
blood processing unit such as a dialyzer preferably with the blood
outlet at the top to facilitate bubble removal. One then pumps the
priming solution through the arterial and venous sets and the blood
processing unit in the second flow direction (i.e., the normal flow
direction which is reversed to the first flow direction), to flush
the sets and blood processing unit, without passing substantial
amounts of air into the blood processing unit.
[0018] This method can be accomplished while pumping the solution
with a flow pump such as a roller pump through the set, which
operates in only a single, pumped flow direction throughout the
entire priming process, the normal, second flow direction described
above. The first flow direction, which is reverse to the second
flow direction, may take place by gravity flow if desired.
Preferably, the arterial and venous patient connectors are
substantially directly connected together throughout substantially
all of the performance of the above method.
[0019] The invention also pertains to a tubular medical fluid set
having an in-line bubble trap chamber having a top wall. The top
wall defines a port which communicates with flow tubing of the
tubular set. The port communicates with a port tube which extends
into the chamber and has a tube end which is spaced below the top
wall, and preferably below the intended blood/air interface. The
tube end defines a wall that directs flow out of the tube
circumferentially into and through the bubble trap chamber. Thus,
blood entering the chamber through the tube is directed
circumferentially about the chamber wall, the effect of which is to
direct bubbles radially inwardly, rather than downward.
[0020] The chamber also preferably defines a baffle to convert
circumferential flow into turbulent flow at positions above the
tube end wall and the circumferentially directed blood and at the
blood-air interface. This prevents formation of a blood whirlpool
having a significant, centrally depressed upper surface. Thus, the
centrally disposed bubbles will rise to the top of the chamber to
join an air space that is typically present there, without being
sucked downwardly as would be caused by the presence of such a
blood whirlpool having a centrally depressed upper surface.
[0021] Accordingly, the flow pattern of blood near the top of the
bubble trap chamber described comprises a top segment of largely
turbulent blood flow, and a lower segment of largely
circumferential blood flow.
[0022] As another aspect of this invention, priming of a tubular
medical fluid set may take place, the set having an in-line bubble
trap chamber, preferably on the venous set. One passes priming
solution into the tubular set preferably at a point pre-pump on the
arterial set and bubble trap chamber, while withdrawing air from
the set through a port in an upper portion of the chamber. The port
communicates with a port tube extending into the chamber in
positions which are spaced below a top chamber wall.
[0023] Further in accordance with this invention, preferably the
in-line bubble trap chamber has an upper portion which defines a
port that communicates with the exterior. The port communicates
with a port tube extending into the chamber, having a port tube
opening spaced below the top wall within the chamber, to
automatically define a predetermined air volume and liquid level in
the chamber approximately at or above the tube opening as the
tubular set is filled with priming solution.
[0024] The bubble trap chamber top wall also may define an axially
depressed portion which, in turn, defines a needle pierceable,
resealable injection site to permit an injection needle of at least
about 1/2 inch needle length to penetrate said injection site and
to communicate with liquid below said liquid level which preferably
is set by the port tube arrangement mentioned above.
[0025] Contrary to the prior art, this injection site carried on
the top wall of a bubble trap chamber resides at a lower position
from other portions of the top wall, providing a desired inner
volume under the other portions for air above a liquid level. In
combination with this, the resealable injection site is carried on
the axially depressed portion of the top wall, so that the
injection site is closer to the liquid level within the bubble trap
chamber, preferably permitting an injection needle of at least
about 1/2 inch needle length to penetrate the injection site and to
communicate with the liquid below the liquid level, while still
permitting an air volume within the bubble trap chamber of
preferably at least about 4 cc. This permits direct access to the
blood by a conventional hypodermic needle from the top of the
chamber, for blood sampling from the chamber injection site,
permitting infusion of the very expensive drug erythropoietin
("EPO"), with pump flushing of the needle several times, drawing
blood into the needle and out again to rinse all possible EPO into
the set and then the patient, to avoid wasting of the highly
valuable material.
[0026] Further in accordance with this invention, a tubular blood
set for transfer of blood between a patient and a blood treatment
device has main blood flow tubing and a flexible branch tube
connected in branching relation to the main tubing. The branch tube
is adapted for connection at its other end to a source of
physiological, cell-free solution, as is conventional.
[0027] As particularly shown in Utterberg et al pending patent
application Ser. No. 09/203,274, filed Dec. 1, 1998, some of the
blood passing through the main blood flow tubing may extend into
the branch tube to form a blood-solution interface, so that a
pressure monitor which is also connected to the branch tube is
protected from contact with blood by the presence of an amount of
cell-free solution in the branch tube and a non-compressible,
air-free pressure sensing path is provided through the cell free
solution and the blood across the interface.
[0028] In accordance with this invention, to suppress pressure
pulses from the main blood line tending to disrupt the
blood-solution interface, a portion of the flexible branch tube is
equipped with pulse suppression means. Such means may comprise a
partially collapsible portion of the branch tube, a ball valve, a
duckbilled valve or the like. The required aspects of the flattened
tube or valve are that relatively unrestricted flow is allowed from
an attached saline bag to the bloodline but flow from the blood
line to the branch tube is suppressed progressively as the negative
pressure in the blood line increases. To preferably accomplish
this, the pulse-suppressing portion of the flexible branch tube is
substantially flattened. Accordingly, this tube portion has a lumen
that can and does reduce its cross-sectional area responsive to
negative pressure in that area to a degree substantially greater
than cylindrical tubing. This results in the suppression of
negative pressure pulses created by the pumping of blood through
the main flow tubing, which negative pressure pulses tend to
disrupt the blood-solution interface in the branch tube. However,
if the tube portion that is flattened is preferably placed in the
branch tube between the blood-solution interface and the main blood
flow tubing, the effect of these negative pressure pulses is damped
at the interface area. However, the tube portion, or an alternative
valve, can increase its cross-sectional area at any time responsive
to positive pressure. Thus, if there is an urgent need to provide
saline solution to the extracorporeal blood flow path in the event
of a crisis, the tube portion or valve can expand back to its
normal cylindrical shape or seating of the valve is less, so that
increased solution flow can pass therethrough.
[0029] The flattened branch tube portion may comprise a flattened
lumen cross section that defines a periphery having at least one
open groove, which is transverse to the cross section, to avoid
complete closing of the branch tube under negative pressure.
Furthermore, a generally cylindrical, flexible branch tube may be
used, the tube being flattened at the tube portion by a removable
slide clamp which comprises a pair of arms defining a slot between
them. The tube portion resides in the slot and, as is preferable,
at least one of the arms defines a transversely extending groove
that forms the open groove in the tube portion.
[0030] Basically, there is no limit to the types of structures that
can be used in a valve function to provide relatively unrestricted
flow from an attached saline bag to the blood line as needed, but
also suppressing reverse flow from the blood line to the branch
tube that connects to the saline bag, to suppress fluid pressure
pulses particularly at the blood-solution interface, as previously
discussed. Particularly, such a valve member closes to restrict
flow (but not completely close) when pressure conditions for
reverse flow are present, but it opens wide under forward flow
pressure so that solution may be quickly added to the blood line.
Thus, hypotensive patients may receive saline quickly through the
system if that is needed, but the same system restricts blood from
the blood line from pushing up the branch line by pressure
oscillations, which mix the blood and the solution and destroy the
discreet blood-solution interface. However, such a valve member
allows enough reverse flow so that line pressures are equilibrated
above the blood-solution interface quickly, so that a hazardous
pressure situation is recognized by the pressure transducer.
[0031] Typically, such a valve allows full, rapid, 100 percent flow
downstream through the branch tube from the solution source to the
blood line, but only allows between about one to fifty percent of
that flow in the reverse direction, typically on the order of five
to twenty percent of the downward flow toward the blood line, under
normal pressure conditions.
[0032] Further in accordance with this invention, a protector for a
female luer connector is provided, which comprises: an outer
sleeve, a central transverse wall defined in the outer sleeve, a
male luer projecting axially within the sleeve from the transverse
wall to engage the female luer connector along with the sleeve. A
tube projects axially within the sleeve from the transverse wall
into the direction opposed to the male luer. The tube and the male
luer have connected lumens, with the tube having an outer end that
is substantially recessed within the sleeve.
[0033] Accordingly, a female luer connector may be used as a air
venting and/or drain line during priming, for example, with
accordance with the teaching of Utterberg U.S. Pat. No. 5,951,870.
However, after priming, rather than closing off this line it can be
used for the addition of supplemental medication, added solution,
or the like because the female luer connector on the end can have
its sterility retained by the protector of this invention.
[0034] Specifically, the protector of this invention has an outer
sleeve inner wall which has screw threads or preferably is free of
screw threads. The sleeve inner wall preferably defines axially
extending ribs at least on the side of the transverse wall that
carries the male luer, to facilitate axially sliding connection and
retention with the female luer connector. Furthermore, it is
preferred for the tube outer end, which does not need to carry a
taper like a male luer, to terminate at a point no more than about
two thirds of the distance from the transverse wall to the end of
the outer sleeve which is opposed to the male luer, so that this
tube serves as a spout for the venting of air and priming solution,
and is retained in aseptic condition, since it is recessed in the
outer sleeve and thus protected.
[0035] Also, it is preferred for a hinged cap to be attached to the
outer sleeve in a position which permits closure of the cap over
the outer sleeve end that is opposed to the male luer, for
preservation of aseptic conditions between priming and subsequent
use of the female luer connector.
[0036] Thus, sets for blood processing are provided which exhibit
significant distinction and advantage over the prior art.
BRIEF DESCRIPTION OF THE DRAWINGS
[0037] For the purpose of facilitating an understanding of subject
matter sought to be protected, there are illustrated in the
accompanying drawings embodiments thereof, from an inspection of
which, when considered in connection with the following
description, the subject matter sought to be protected, its
construction and operation, and many of its advantages should be
readily understood and appreciated.
[0038] Referring to the drawings, FIG. 1 is a plan view of a
combined arterial and venous set system in accordance with this
invention, with the respective ends of the arterial and venous sets
being connected together to form a closed loop prior to use;
[0039] FIG. 2 is a fragmentary, perspective view of the bubble trap
chamber of the venous set of FIG. 1;
[0040] FIG. 3 is a sectional view taken along line 3-3 of the FIG.
2;
[0041] FIG. 4 is a perspective view of the underside of the top cap
of the chamber of FIG. 2;
[0042] FIGS. 5 and 6 are perspective views of a sliding clip
utilized in the set arrangement of FIG. 1.
[0043] FIG. 7 is an enlarged longitudinal sectional view taken
along line 7-7 of FIG. 1;
[0044] FIG. 7A is an enlarged sectional view taken along line 7A-7A
of FIG. 1;
[0045] FIG. 8 is an enlarged longitudinal sectional view taken
along line 8-8 of FIG. 1;
[0046] FIG. 9 is an enlarged longitudinal sectional view taken
along line 9-9 of FIG. 1;
[0047] FIG. 10 is a partial longitudinal sectional view similar to
FIG. 9 but rotated 90 degrees about the longitudinal axis;
[0048] FIG. 11 is a highly enlarged, longitudinal sectional view of
a portion of the set system of FIG. 1, showing an alternative
embodiment;
[0049] FIGS. 12 and 13 are enlarged portions of FIG. 11, showing
the range of motion of a valve ball;
[0050] FIG. 14 is a sectional view taken along line 14-14 of FIG.
11, with the valve ball omitted;
[0051] FIG. 15 is a longitudinal sectional view similar to FIG. 11,
but showing an alternative embodiment in which the pulse
suppression device is a partially disabled duckbill valve;
[0052] FIG. 16 is a front perspective view of the duckbill valve of
FIG. 15;
[0053] FIG. 17 is a longitudinal sectional view of an in-line
chamber, which may be used in a branch line in accordance with this
invention, having a different design for a pulse suppression
member; and
[0054] FIG. 18 is a perspective view of the pulse suppression
member used in the chamber of FIG. 17.
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
[0055] Referring to the drawings, FIG. 1 shows a combined arterial
set and a venous set 10 for hemodialysis comprising arterial set 12
and venous set 14, which sets may be used in the conventional
manner in conjunction with a conventional dialyzer 16 for the
performance of hemodialysis. Hemodialyzer 16 may be replaced with a
hemoperfusion device or another flow through blood treatment device
as may be desired.
[0056] Arterial set 12 comprises a patient connector 18, which is
connected to set tubing 20, closeable by a conventional pressure
clamp 22. Set tubing 20 communicates with connector 24 for roller
pump tubing 44 and having a branch tubing 28 extending out from
connector 24.
[0057] Branch tubing 28 connects with chamber 29, which connects
with tubing 30 that communicates with a pressure monitor 37 by
connector 36. Chamber 29 also connects with a second branching tube
38, which connects with a source of physiological priming solution
40 for priming of the set, and also for administration to the
patient as needed during the dialysis procedure.
[0058] Roller pump tubing 44 may be fitted within a roller pump
system 46 for pumping of fluid through the set system. Branch
tubing 50 may extend from second pump tubing connector 48 for
additional connection access to the system, such as for connection
to a heparin source. Connectors 24, 48 may be as disclosed in
Utterberg U.S. Pat. No. 5,360,395.
[0059] Arterial set 12 has an additional length of tubing 52 that
extends from roller pump tubing connector 48 to arterial unit
connector 54, which is proportioned to connect to arterial end 56
of dialyzer 16. However, by this invention, arterial unit connector
54 is integrally connected with a frangible seal 58 to venous unit
connector 60, which is adapted to connect with the venous blood
port 62 of dialyzer 16. Preferably, sleeve 63 (FIG. 10) surrounds
the frangible section to help prevent touch contamination of the
sterile areas during franging (breaking apart). Thus, in an initial
condition as shown, unit connectors 54, 60 are initially connected
together, being frangibly breakable along line 58, which then
subsequently permits them to be connected to the respective ports
56, 62 of dialyzer 16 at a desired step in the process of setup of
a dialysis system. Each connector 54, 60 has an integral closure
cap 61.
[0060] Unit connector 60 of venous set 14 connects with flexible
tubing 64, and communicates into venous bubble removal chamber 66
through the top cap thereof. In normal flow, blood in chamber 66
passes through filter 70 and into venous tubing 72, closeable by
conventional squeeze clamp 74, to connect to patient venous
connector 76. Both patient connectors 18, 76 are essentially
directly connected together preferably prior to sterilization of
the set by the engagement of their respective threaded sealing caps
78, 80 by means of a tubular double connector tube 82, which
provides sealing fluid connection between the respective tubular
sets and connectors 18, 76 while permitting disconnection when
desired. For example, patient arterial connector 18 may be
disconnected from double connector 82, and then cap 84 may pivot
around to close double connector 82 to retain sterility in the
venous patient connector 76, while arterial patient connector 18 is
being joined to a fistula needle, for example, and connection to
the patient's fistula is being effected.
[0061] In accordance with this invention, the arterial and venous
sets 12, 14 are connected together in basically a loop form by the
integral joining of unit connectors 54, 60 along frangible line 58,
and by the mutual joining of arterial and venous patient connectors
18, 76 with double connector tube 82. Preferably, the set may be
received in this form in sterile condition from the manufacturer to
the site where the dialysis is to be performed. The system is
mounted in a dialysis machine, without connection to dialyzer 16,
in the closed loop condition of FIG. 1. Alternatively, connection
may be initially made at this point between unit connectors 54, 60
and dialyzer 16, particularly when an internally dry, typically
unused dialyzer 16 is provided.
[0062] Otherwise, the direct connection between unit connectors 54,
60 may be maintained during the first steps of priming particularly
in that situation where dialyzer 16 has a wet interior because it
has been previously used, and has been resterilized by conventional
processes. Priming solution from container 40 passes through branch
tubes 38, 28, filling chamber 29 as well as the rest of the
arterial and venous set system by pumping of roller pump 46 to
cause solution flow in direction 86. If desired, simultaneously or
sequentially in either order, solution may also flow in a reverse
direction through tube 20 per arrow 87, typically by gravity
solution flow, through the connection between patient connectors
18, 76 and through tubing 72 in direction 87, to fill chamber 66
from the bottom, thus avoiding the trapping of air bubbles in
filter 76, with air being vented through branch tubing 88.
[0063] By this means, the respective, joined sets 12, 14 can be
substantially filled with priming solution, and all undesired air
is driven out of the set. Then, if not before, unit connectors 54,
60 may be separated and connected to the respective ports 56, 62 of
dialyzer 16, and further circulatory flow may pass through the
entire system in direction 86, driven by roller pump 46, for the
final recirculation, flushing, and/or rinsing procedure prior to
introduction of blood to the system through arterial patient
connector 18 and return of blood through connector 76.
[0064] A major advantage for performing initial filling and priming
of dialysis sets 12, 14 in the form of an interconnected loop
without dialyzer 16 results from the fact that priming can then
take place without the insertion of additional air through the
dialyzer. A wet dialyzer will trap air bubbles in its membrane,
resulting in a reduction in dialysis efficiency, so the efficiency
is improved by filling the arterial and venous sets 12, 14 first,
and then connecting with particularly a wet dialyzer 16 for the
completion of the priming process, which process may be
conventionally performed from then on. Specifically, flow pump 46
may be a conventional unidirectional pump which pumps in only one
flow direction as needed throughout the entire priming process.
Bidirectional flow from chamber 29 may take place simultaneously in
both directions 86 and 87 if the flow rate of priming solution
through tube 28 is greater than the flow rate through pump tubing
44, the excess of the solution flowing in direction 87 through tube
20 for a rapid, bidirectional priming of the respective sets 12,
14.
[0065] Referring further to FIGS. 2 through 4, venous bubble
removal chamber 66 comprises a body 85, typically with a tubular
cross section, and top cap 89, having a series of apertures for
connection with tubing. One of such connections comprises main
venous flow tubing 64, while another of the connections comprises
branch tubing 88, through which venting of air and priming solution
may take place during the priming process.
[0066] Cap 89 may also define an aperture which holds needle
pierceable injection site 90, of conventional design except as
otherwise described herein. Port 91 connects to pressure monitor
line 93 (FIG. 1).
[0067] In accordance with this invention, flow tubing 64
communicates through cap 89 into communication with port tube 92
extending into the interior of chamber 66 and cap 89, having an
inner tube end 94 extending below top wall 96 of cap 89. Tube end
94 comprises a wall (of the same reference number) that directs
flow through the tube circumferentially of the bubble trap chamber,
through side aperture 98. Thus, blood inflowing through tube 92 is
directed to flow around the inner circumference of chamber 66.
[0068] Branch tube 88 communicates with baffle tube 100, which
enters the chamber 66 through top wall 96, and terminates at a
level which is preferably closer to top wall 96 than is aperture 98
of inlet tube 92. Thus, baffle tube 100 communicates with the
chamber interior, and also serves as a baffle along with tube 92 to
convert circumferential flow at its level in chamber 66 into
turbulent flow, at positions above tube end wall 94 and aperture
98. Thus, inflowing blood provides a rapidly rotating area of blood
at approximately the level of aperture 98. However, at areas nearer
to top wall 96, baffle tube 100 and tube 92 interfere with the
circumferential flow of blood and cause turbulence, which prevents
formation of a blood whirlpool having a significant, centrally
depressed upper surface. Nevertheless, the rapid, circumferential
flow of blood at the level of aperture 98 and slightly below in
chamber 66 causes microbubbles in the blood to be driven to the
center of rotation, where the microbubbles can rise upwardly
through the turbulent blood area at the level of baffle tube 100,
to collect under wall 96 and join in a gas bubble or air space 103
there.
[0069] This airspace 103 is spontaneously formed during the priming
of this set in chamber 66, which airspace defines a liquid level
101 at about the lower edge of baffle tube 100 at ambient pressure.
This is because air is vented out of baffle tube 100 and branch
tube 88 during priming. Thus, when sufficient air has been vented
so that the blood level rises to reach tube 100, air venting stops.
Fluid preferentially passes up tube 100, and the air above the
lower end of tube 100 is trapped. Then, during operation under a
positive pressure as provided by roller pump 46, the airspace 103
will compress, and the liquid level will rise to a degree above the
lower end of tube 100. Thus, the desired liquid level can be
spontaneously formed in chamber 66 on priming.
[0070] The air in monitor tube 93, transducer filter 99 and the
pressure monitoring tubing within the dialysis machine 101 have a
fixed air volume.
[0071] The position of the lower end of baffle tube 100 and the
related position of opening 98, assure that enough air volume at
ambient pressure exists in chamber 66 to prevent liquid entering
monitor tube 93 when the system is fully pressurized at operating
flows. Because cross contamination deaths have occurred when blood
from one patient broke through a transducer filter and contacted
viruses from a previous patient using the same machine, this
invention has great power to save lives. Given the air volume of
various machines on the market, the air volume at ambient above
tube end 100 within chamber 66 is preferably at least 4 cc to
attain this safety advantage.
[0072] In another embodiment of this invention shown in FIG. 3, top
wall 96 of bubble trap chamber 66 defines an axially depressed
portion 104 which, in turn, defines the needle pierceable,
resealable injection site 90. Thus, a conventional injection needle
of at least about 1/2 inch needle length can be placed through
injection site 90 to penetrate the injection site and to
communicate with liquid level 101 within chamber 66. As previously
described, this permits continuous contact with the blood supply in
chamber 66, so that EPO, for example, may be administered with
pump-flushing, where blood is drawn into the needle and
reintroduced back into the chamber to rinse virtually all EPO from
the interior of the needle and syringe, thus assuring essentially a
100 percent administration of the valuable drug. Air volume in
chamber 66 typically of at least 4 cc, in combination with the
invention of depressed portion 104 for the position of injection
site 90, can provide the combined benefits of sufficient chamber
volume for anti-transducer protector wet-out, and use of 1/2 inch
needles as described above.
[0073] Further in accordance with this invention, in FIG. 1 second
branch tubing 30 communicates with a conventional pressure monitor
37. As described in the previously cited patent application Ser.
No. 09/203,274, it is desirable to connect pressure monitor 37 with
a substantially incompressible liquid pressure transfer path
through second branch line 30, chamber 29, and branch line 28
without a significant amount of compressible gas such as air being
present, except for a small amount of air in the tubing next to the
transducer protector so that the transducer protector is not wetted
with solution. Also, a small amount of air is present in the tubing
of the transducer device itself. As described above, it is highly
undesirable for blood to enter pressure monitor 37, which is also
connected to dialysis machine 101. Even if a normal protector is
used, it is clearly better for the blood to be spaced from pressure
monitor 37. To this end, upon priming, second branch line 30 may be
filled with priming solution which remains to provide the
substantially more incompressible liquid pressure transfer path,
and also to space the blood from pressure monitor 37. Thus, upon
operation of the arterial and venous sets 12 and 14 to transfer
blood, a blood-solution interface 106 may be formed typically in
branch line 28, so that a continuous liquid pathway is provided to
pressure monitor 37, without the blood getting near to the
monitor.
[0074] However, the pumping action of roller pump 46 against pump
tubing 44 causes an oscillation in the pressures in the sets,
including branch lines 28, 30. Because of the higher density of
blood relative to that of saline, this oscillation tends to cause
the blood-solution interface 106 to break up, with blood mixing
into the solution. To address this, a slide clamp 108, shown in
FIGS. 1, 5 and 6, may be provided to substantially flatten a
portion of branch tube 28, i.e., that portion which occupies the
interior of slide clamp 108. Slide clamp 108 is preferably
positioned between blood-solution interface 106 and connector
24.
[0075] As shown in FIGS. 5 and 6, slide clamp 108 comprises a pair
of arms 110, 112 defining a slot 114 between them. The flattened
tube portion resides in slot 114. Contrary to other slide clamps,
slide clamp 108 is proportioned in slot 114 so that flow is not
completely blocked through tube 28, but tube 28 is merely flattened
within clamp 108.
[0076] It is further preferred for at least one of arms 110, 112,
specifically shown to be arm 110, to define a transversely
extending groove 116. Groove 116 forms in the flattened portion of
branch tube 28 a corresponding open groove which is generally
parallel to the longitudinal axis of the branch tubing, to avoid
complete closing of the branch tube under negative pressure. Since
slide clamp 108 has a slot 114 of a width which does not completely
close branch tubing 28, it merely puts the enclosed section of
branch tube 28 into a substantially flattened configuration, with
the result that negative pressure pulses tend to cause the
flattened tubing to transiently and spontaneously lose lumen area
by at least partial collapsing, thus damping the effect of the
oscillatory pressure and preserving the integrity of precise
blood-solution interface 106, while still permitting transfer of
pressure in set 12 to sensor 37.
[0077] However, in the event of an emergency, where the patient
needs solution with utmost urgency on a life-threatening basis,
slide clamp 108 can be quickly removed from branch tube 28, and
roller clamp 39 can be opened wide for rapid solution
administration. The flattened portion of branch tube 28 can expand
out to cylindrical shape again, and thus, it does not provide a
barrier to high volume solution administration. Additionally,
second branch tubing 30 can be put into action to provide added
solution, by disconnecting it from pressure monitor 38 and
connecting it to a new source of solution.
[0078] As another preferred alternative to the use of slide clamp
108 to stabilize blood-solution interface 106 in the presence of
oscillatory pressure in the set 10, pump tubing connector 24 can be
modified as connector 24a in the manner illustrated in FIGS. 11-14,
with slide clamp 108 being not used. Alternatively, another
connector or tube of branch line 28 below saline/air interface 106
may be modified in equivalent manner as described below.
[0079] Connector 24a connects to pump tubing 44 at one end and to
blood flow line 20 at the other end as in the previous embodiment,
and injection site 25 is provided, being filled with an
elastomeric, needle piercing material. Transverse bore 27
communicates between the central bore 29 of connector 24a, all in a
manner similar to the known design of connector 24.
[0080] Also, connector 24a provides a parallel connection to branch
line 28 as in the previous embodiment.
[0081] By way of modification, connector 24a carries a valve which
comprises a ball 130, which is trapped in a space 134 that
communicates with branch tubing 28 and branching bore 27. Ball
valve 130 is capable of moving through a range of horizontal
positions (from the viewpoint of FIGS. 11-13), with the extremes of
movement range being shown. In FIG. 12, ball 130 is restrained from
further movement to the left by the presence of cross bar 132,
which extends across an end of space 134, which space communicates
with transverse bore 27. At the right limit of motion of ball 130,
as shown in FIG. 13, ball 130 is stopped from movement by the
smaller, inner diameter of branching tubing 28. However, as shown
in both FIGS. 12 and 13, branch tubing 28 defines a cut-out portion
136. Thus, ball valve 130 has the rare characteristic of being
intentionally disabled from completely sealing against flow between
transverse bore 27 and tubing 28, although ball valve 130 in its
position of FIG. 13 constricts and reduces the magnitude of that
flow significantly.
[0082] Similarly, at the left hand position of FIG. 12, ball 130,
resting against cross bar 134, still provides an open channel for
flow of solution from solution source 40 through branch line 28
into transverse bore 27 and the main blood flow line comprising
tubing sections 20 and 44.
[0083] The normal flow conditions within connector 24a are
generally subatmospheric or negative pressure conditions, since
connector 24a is upstream of pump 46. Ball 130 oscillates back and
forth as the oscillatory negative pressure conditions created by
pump 46 are transmitted through the liquid to the ball. As ball 130
oscillates into its right hand extreme position of FIG. 13, driven
by pressure peaks of less negative pressure than the troughs of
oscillatory pressure, it suppresses the transfer of liquid upstream
into branch tubing 28, thus suppressing the fluid oscillations and
pressure pulses that tend to disrupt blood-solution interface 106.
Nevertheless, significant pressure changes in the system can pass
through the barrier provided by ball 130 to reach pressure monitor
37, so that alarm conditions can be noted and signaled despite the
flow restriction provided by ball 130, which tends to stabilize
blood-solution interface 106.
[0084] If desired, the ball valve incorporating ball 130 could be
placed in branch line 28 or in the bottom of chamber 29. Also, a
duckbill-type valve imparting similar flow characteristics, or
other valves, could be used.
[0085] Thus, the following effects are achieved:
[0086] 1. Relatively free flow of saline from tube 30 to arterial
line 12 when I.V. clamp 31 is opened. This is for the reason of
quickly alleviating hypotensive episodes whenever they occur (as
well as for rapid priming of the set to save the nurse time). Thus,
the valve should be in an open position whether the driving
pressure is only the head pressure of the saline bag 40 vs a near
ambient pressure in the blood line (when blood pump 46 is off or
flowing slowly) or when the driving pressure is high because the
bloodline pressure is heavily negative due to the sucking of
rapidly flowing bloodpump 46 against the restriction of the
arterial fistula needle (not shown).
[0087] 2. Suppression of blood pressure pulse when I.V. clamp 31 is
closed and blood pump 46 is flowing. At low flows the pulse is
neither strong or rapid and so the valve doesn't have to seat
strongly (i.e. fluid can pass from the arterial line 12 to the I.V.
line 28). Because the density of blood is greater than saline, the
saline/blood interface 106 without intervention breaks down as the
pulse quickens and hammers with increasing force. Thus, as the
bloodpump 46 quickens its rotor speed (quicker pulses) and the
blood pressure becomes more negative (higher flows sucking through
the fistula needle) the force and the pace of the pressure pulse
quickens. Further, at low flows and pressures the "volume" of the
pulse is small so fluid passing back through the valve does not
harm the blood/saline interface or move its position.
[0088] At high flows, the valve ball 130 seats somewhat more
securely. It still passes fluid in order for the correct pressure
to be read at transducer filter 36 (timed delayed because of the
pulse suppression), but not so much as to give the blood pulse
enough force and inertia to destroy the blood/saline interface. It
should be noted that the pulse is typically from a higher negative
to a lower negative pressure, rather than from a negative to a
positive pressure.
[0089] The embodiment of FIGS. 15 and 16 how a common duckbill
valve 150 can be modified and used to provide pulse suppression
means of the type described above. FIG. 15 is similar in structure
to FIG. 11, except for the type of pulse suppression means shown
(the duckbill valve).
[0090] Branch line 28 from the set of FIG. 1 connects with
connector 24b, which, like connector 24a, is positioned to provide
double connection with pump tubing 44 and blood tubing 20.
Injection site 25b is provided, being similar to injection site 25
of the previous embodiment. Transverse port 27b is similar to
transverse port 27 of the previous embodiment, as are other
components of connector 24b, except as otherwise described.
[0091] Particularly, the moveable ball 134 of the previous
embodiment is replaced by duckbill valve 150, with valve 150
performing the same function as the moveable ball in the previous
embodiment.
[0092] Referring to FIG. 16, a perspective view of duckbill valve
150 is shown. Valve 150 may be a common, commercially available
rubber duckbill valve which operates as a one way valve in an
entirely known manner. However, in accordance with this invention,
one or more holes 152 are punched into valve 150, so that the
permitted flow in the direction from connector 24b and through
branch tubing 28 is restricted but not completely blocked, so that
constant pressure communication between the blood line and branch
tubing 28 is achieved moment-by-moment. At the same time, high
volume flow through branch line 28 to connector 24b and from there
to the blood flow circuit remains possible. Typically, the fluid
backflow through duckbill valve 150 into branch line 28 can be
about five percent of the forward liquid flow from branch line 28
into the blood flow circuit at pressures normally used, so that
pressure pulses do not disrupt blood-solution interface 106.
[0093] FIGS. 17 and 18 show another embodiment of pulse suppression
means in accordance with this invention.
[0094] FIG. 17 shows in line chamber 29a, serving as a substitute
for chamber 29 in FIG. 1. The pulse suppression member 160 occupies
chamber 29a, thus being positioned at the end 171 of branch line
28, which is opposed to the end of the branch line which connects
with connectors 24, 24a, and 24b in the various embodiments. This
shows the wide variability of the location of the pulse suppressing
member for protection blood-solution interface 106. Chamber 29a
connects at its bottom with branch tubing 28, and, like the
embodiments of FIGS. 11-15, no sliding clamp like clamp 108 is
required. At the top, chamber 29a may connect with tubing 30 which,
in turn, connects with a pressure monitor 37. Chamber 29a also
connects with tubing 38, which connects with the source of solution
40.
[0095] Chamber 29a carries a movable arrowhead member 160 as the
pulse suppression means, which reciprocates for a short distance
upwardly and downwardly in chamber 29a, being wider than and thus
retained by constricted neck 162 of chamber 29a, through which
constricted portion 163 of arrowhead member 160 extends. Head 164
of arrowhead member 160 is positioned above constricted neck 162
and, as shown in FIG. 18, is flattened on its respective sides as
shown to provide a second dimension of width that is no more than
half the wider dimension of width. Thus, when positive pressure is
present in chamber 29a, there is still good room for flow of fluid
out the bottom of chamber 29a, past the flat faces 166 of head 164
into tube 28. However, when a pressure pulse in branch line 28 is
projected upwardly to arrowhead number 160, the pulse strikes
flanged bottom 168 of arrowhead member 160, driving arrowhead
member 160 upwardly so that flange 170 engages annular, constricted
neck 162 of chamber 29a. However, this does not absolutely halt
upward flow from tube 28 into chamber 29a, by the design of the
system. Typically, one would engineer a valve-like structure of
this type to seal well. However, in this instance, the system will
be designed to seal only partially, providing a leaking upward flow
that is at least one percent of the downward flow through the same
system from chamber 29a. This can be accomplished in a variety of
ways; by one or more longitudinal grooves or apertures in flange
170, by simply roughening the surface of flange 170 to allow a
small amount of upward flow in all conditions, by adjustment of the
draft angle in the vicinity of flange 170, or by a combination of
these techniques.
[0096] Thus, as an oscillatory pressure from the blood line is
provided through branch tube 28, arrowhead member 160 oscillates
upwardly and downwardly, suppressing but not eliminating the flow
and pressure communication between branch line 28 and chamber 29a.
Thus, the pressure conditions are damped in branch line 28, having
the effect of tending to preserve the integrity of blood-solution
interface 106.
[0097] Inlet flow distribution member 172 has a closed bottom end,
but allows the flow of solution to enter chamber 29a sideways
through a plurality of apertures 176, so that the solution tends to
impinge the wall of chamber 29a upon rapid infusion.
[0098] Another example of the pressure pulse suppression means may
simply be provided by the use of a relatively enlarged diameter of
branch tubing 28. For example, when a maximum flow through blood
flow line 20, 44, 52 is about 500 ml. per minute and a two roller
pump 46 is used pressure, pulses may be significantly suppressed by
the use of a branch tube 28 having an inner diameter of at least
4.5 millimeters and preferably 5-8 mm. In a specific embodiment of
this, pump segment tubing 44 may have an inner diameter of eight
millimeters and an outer diameter of 12 millimeters. Thus,
blood-solution interface 106 is not seriously disturbed by pressure
oscillations, which oscillations are damped by the larger diameter
tubing 28.
[0099] Further in accordance with this invention, venting line 88
may carry a connector 110 such as a female luer (FIGS. 1 and 7),
which, by this invention, may be subsequently used for other
purposes by retention of its aseptic condition while being used for
venting. For example, it also can be connected to a solution or
blood container in the event of an emergency.
[0100] A protector 112 is provided for connector 110, which
protector comprises an outer sleeve 114, and a central, transverse
wall 115 defined in outer sleeve 114. A male luer 116 projects
axially within sleeve 114 from transverse wall 115 to engage the
female luer connector 110 along with sleeve 114, so that the female
luer connector 110 is enclosed within and without. A tube 118
projects axially within sleeve 112 from the transverse wall 115 in
the direction opposed to male luer 116, the tube and male luer
having connected lumens 120. Tube 118 has an outer end that is
substantially recessed within the sleeve 114. Thus, aseptic
conditions can be retained as air and priming solution pass through
tube 88 during priming and out of female luer 110, due to the
protective action of the protector of this invention.
[0101] It should be noted that sleeve 114 may have an inner wall
which is free of screw threads, but rather defines axially
extending ribs 122 to facilitate axially sliding connection and
retention with luer connector 110. Also, a hinged cap 124 may be
attached to outer sleeve 114 in a position which permits closure of
the cap over the outer sleeve end 126 that is opposed to the male
luer 116, to surround and seal it.
[0102] By this means, the female luer connector 110, even though
wet, can be aseptically protected so that it can be reused in
another function during the blood treatment process if needed.
[0103] The above has been offered for illustrative purposes only,
and is not intended to limit the scope of the invention of this
application, which is as defined in the claims below.
* * * * *